Klinikai kutató állások, munkák

• Plan and perform drug discovery contract research studies
• Executing bioassays
• Data evaluation and interpretation
• Prepare study reports in English
• Summarize data, analyze results and formulate conclusion
• Work with other project team members and communicate results with the team

• klinikai kutatásokban való részvétel
• dokumentáció vezetése és adatrögzítés
• folyamatos kapcsolattartás és együttműködés a kutatásban részt vevő betegekkel, orvosokkal és ápolókkal
• kutatással kapcsolatos betegdokumentáció pontos kezelése
• biológiai minták protokoll szerinti adminisztrációja

• laboratóriumi mérések készítése és új vizsgálatok elindítása
• kísérlethez kapcsolódó molekuláris mérések elvégzése
• kutatások megtervezése és kivitelezése
• részvétel a medikusok oktatásában

• Start date:
• Latest Start Date:
• Planned duration: 6 months
• Extension: not likely (maternity leave)
• Max. Bill Rate: CHF (Depends on the experience)
• Workplace: Basel
• Workload: 100%
• Home Office: No
• Travel: No
• Team: 5-10 people
• Working hours: Standard

• Risk Identification & Assessment - Analyze risks related to product development, manufacturing, post market, useability, biocompatibility, cybersecurity, vigilance, compliance, etc..
• Implementation of Risk Controls - Develop strategies to minimize risks and improve processes.

• Support validation activities for equipment, processes, and systems
• Assist in the preparation and execution of validation protocols (IQ/OQ/PQ)
• Review and maintain GMP documentation
• Collaborate with cross-functional teams such as Production, Quality Assurance, and Engineering

• Strategic planning, execution, and oversight of international Phase I clinical trials in accordance with GCP/ICH-GCP guidelines, regulatory requirements (EMA/FDA), and internal SOPs
• Preparation, review, and approval of all relevant study documents in collaboration with external service providers

• Design and execute experiments for purification of recombinant proteins
• Analyze and interpret data to guide process development and troubleshooting
• Collaborate cross-functionally with other RnD teams
• Contribute scientifically to the project progress, lead project discussions and development

The Advanced Workflow Specialist â Electron Microscopy Sample Preparation (d/f/m) plays a key customer-facing role within the EMEA Business Development team. The position supports pre-sales and post-sales activities by delivering expert application knowledge, demonstrations, trainings, and workflow...

• Take full responsibility for the product portfolio throughout its entire lifecycle - from concept to phase-out
• Derive market and customer needs and translate them into clear product requirements and strategies

Management of projects from conception, development work, verification, manufacturing, validation and ultimately product commercialization, in accordance with Hygiena's Product Commercialization Process (PCP)....

Koordination und technische Leitung interdisziplinärer Entwicklungsteams in Bezug auf das technische Management von Entwicklungsprojekten, Projektplänen, Ressourcenplänen und die Erfüllung von Designanforderungen zur Produktoptimierung...

Unterstützung innerhalb der F&E-Abteilung/Einführung neuer Produkte (Neuproduktentwicklung und Innovation) und anderer geschäftskritischer und/oder umsatzfördernder Maßnahmen von der Planung bis zur Kommerzialisierung...

Govern and steer the innovation pipeline, ensuring effective project management of all innovation initiatives in line with stage gate principles...

• Development new formulations: contribute to design of studies, perform experiments and prepare reports
• Develop analytical methods (e.g. HPLC)
• Prepare and characterize large number of formulations following DOE
• Assist in the development of methods to characterize formulations or raw materials

Collaborate closely with Translational Science Leads (TSL), Clinical Operations, Biostatistics/Bioinformatics, and Data Management teams to execute translational science strategies in clinical trials....

Develop and manage clinical project plan, timelines, and budgets end to end; clinical research, through pre-clinical evaluations, clinical trials and publications, to user guidelines and post-market evidence generation....

• Batch record review for API and bulk product for monoclonal antibody prefilled syringes
• Assessment and documentation of product deviations, OOS, and changes
• Quality oversight for relevant service providers, including CMO's, laboratories, technical operations and supply chain

Management of safety operations incl. corresponding service providers, creation and maintenance of reporting rules (in collaboration with the department Global Safety Application Management) and license partner obligations with respective compliance outputs (e.g. KPIs, PSMF)...

• PhD in biochemistry, protein chemistry, or a related biological science
• Strong hands-on experience in peptide and protein chemistry, including solid-phase peptide synthesis and chemoselective ligation techniques